A Pharmacokinetic Study to Access How the Body Absorbs and Removes ABT-199 in Adults With Non-Hodgkin's Lymphoma

Phase 1

Withdrawn

• Conditions: Relapsed/Refractory Non-Hodgkin's Lymphoma
• Interventions: Drug: [14C]ABT-199 (GDC-0199)

• Registration Number: NCT02095574
• Lead Sponsor: AbbVie

Brief Summary

A pharmacokinetic study to access how the body absorbs and removes ABT-199 in adults with Non-Hodgkin's Lymphoma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-03-21
• Study First Posted: 2014-03-26
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-12
• Last Update Posted: 2014-08-13
• Study Start: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Subject must have relapsed or refractory disease.
2. Subject must have histologically documented diagnosis of non-hodgkin's lymphoma as defined by a B-cell neo-plasm in the World Health Organization (WHO) classification scheme except as noted in exclusion criteria.
3. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
4. Subject has adequate bone marrow (independent of growth factor support per local laboratory reference range).
5. Subject has adequate coagulation, renal and hepatic function.

Exclusion Criteria

1. Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), mantle cell leukemia (MCL), or small lymphocytic lymphoma (SLL).
2. Subject has undergone an allogeneic stem cell transplant.
3. Subject is receiving combination anti-retroviral therapy for human immunodeficiency virus (HIV) (due to potential drug-drug interactions, as well as the potential for increased risk of opportunistic infections).
4. Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease within 6 months that in the opinion of the Investigator would adversely affect his/her participation in this study.
5. Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]ABT-199	[14C]ABT-199 (GDC-0199)	Subjects with relapsed or refractory Non-Hodgkin's Lymphoma

Primary Outcome Measures

Name	Time	Method
Time to Cmax (Tmax) for ABT-199 and [14C]ABT-199	For approximately 9 days following a single oral dose of [14C]ABT-199
Maximum observed plasma concentration (Cmax) of ABT-199 and [14C]ABT-199	For approximately 9 days following a single oral dose of [14C]ABT-199
Area Under the Time curve (AUC) for ABT-199 and [14C]ABT-199	For approximately 9 days following a single oral dose of [14C]ABT-199	The area under the exposure-time curve from time zero to Day 9 and time zero extrapolated to infinite time for single dose of \[14C\]ABT-199

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects with adverse events	At each visit (daily for approximately the first 9 days)	Adverse event monitoring, lab test assessment, physical exam and vital signs will be evaluated throughout the study.
Number of subjects with adverse events	At each visit (daily for approximately the first 9 days)	Adverse event monitoring, lab test assessment, physical exam and vital signs will be evaluated throughout the study.